Officer – QC Full Time NEW

Qualification: MSc

• Approval authority:
• Extra page issuance form.
• Batch internal release certificate and transfer note.
• Breakdown memo perform impact analysis on product quality and sign for QA.
• Tool set checking record.
• Release of bulk product for further stage.
• Key execution support for on-the-floor QA activities.
• Witness key operation steps:
• Area cleanliness and Cleaning Schedules.
• Equipment cleanliness.
• Start-up Activities.
• Cleaning Documentation.
• Verify key activities:
• Monitor GMP and compliance activities:
• Clean equipment.
• Equipment cleaning and use logs.
• Documentation practices.
• Labelling practices throughout operations.
• First coded approvals
• Reporting of Internal quality observations.
• Reporting of incidents.
• Bulk batch approval to proceed.
• Follow-up on open investigations, CAPA and audit observations.

TASKS

• Follow procedures for area QA oversight.
• Collection and transfer of samples (completion of test request) as per approved batch record or protocol.
• Verification of the sampling instrument cleanliness.
• Perform in-process checks or verifications as required in QA approved batch records or protocols.
• Reviewing of the batch manufacturing record for its completeness and reporting of the BMR observation.
• Direct support during key production activities:
• Process validation execution, including raw data checks and report preparation.
• Characterization batches.
• Various other approved protocols.
• Preparation and trending of key process information and/or reports in support of protocols, CPV, incidents or CAPA follow-up.
• Supporting operations in assisting or providing and documenting training when Required.
• Suggest improvements to reduce chance for errors.